Last week in Boston I was honored to give a presentation at the 10th Biosimilars America conference. But, as is often the case at good events, it was more about what I learned than what I had the chance to say.
Or, as my father used to remind me, “Listening is not just waiting for your turn to talk.”
Of the many fine presentations, I refer specifically to the talk given by John Pakulski, head of US Biopharmaceutical Regulatory Affairs at Sandoz, and the current chair of the GPhA Biologics Task Force.
John made many interesting and important points, but the one that resonated the most was that, in an age of technology, we must use technical data more and rely on clinical trials less. In short – when it comes to understanding the complicated concept of biosimilarity (from both regulatory as well as clinical perspectives) it’s a brave new world. But will we have the courage to move beyond “the gold standard.” Perhaps we should say, “the 20th century gold standard.”
Claude Debussy said, “Music is between the notes.” And the same can be said for biosimilarity. We now have many thoughtful guidance documents but, in many respects, it’s just theory. And just like with music theory, the words on the page are one thing – but when talented performers sit down at different pianos in disparate venues the result is both similarity and uniqueness.
In other words – creativity happens.
Another difference between biosimilars and small molecule generics is that the developers of biosimilars are very much in the innovation business.